NCT07239648

Brief Summary

Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between "preoperative exposure factors and postoperative delirium incidence" and "postoperative delirium and long-term adverse outcomes", and clarify the predictive factors and prognostic impacts of postoperative delirium.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Oct 2025Dec 2026

Study Start

First participant enrolled

October 31, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative delirium

    accessed by CAM-ICU/3D-CAM

    within 1 week after operation

Secondary Outcomes (3)

  • subtype of delirium

    within 1 week after operation

  • severity of delirium

    within 1 week after operation

  • duration of delirium

    within 1 week after operation

Study Arms (2)

delirium group

patient developed postoperative delirium

Diagnostic Test: Serum metabolic profile

control group

patient don't develop postoperative delirium

Diagnostic Test: Serum metabolic profile

Interventions

Venous serum samples are analyzed for serum metabolic profiles or other test

control groupdelirium group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing elective cardiac surgery

You may qualify if:

  • years old and above
  • Patients undergoing elective cardiac surgery

You may not qualify if:

  • Organ transplantation surgery
  • Pregnant patients
  • Diagnosed with dementia or mental illness (such as schizophrenia) before surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

5ml of venous blood

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Chong Lei, M.D.& phd

CONTACT

Zefei Zhang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, Head of Anesthesia Clinical Research Center, Xijing Hospital

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

October 31, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations